1 / 12

Safety and Efficacy of Mapracorat Ophthalmic Suspension in the Treatment of Inflammation Following Cataract Surgery: Ad

Safety and Efficacy of Mapracorat Ophthalmic Suspension in the Treatment of Inflammation Following Cataract Surgery: Adaptive Design Study. Timothy L. Comstock, OD Oliver D. Schein, MD Tuyen Ong, MD Karen Kesler, PhD

vahe
Download Presentation

Safety and Efficacy of Mapracorat Ophthalmic Suspension in the Treatment of Inflammation Following Cataract Surgery: Ad

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Safety and Efficacy of Mapracorat Ophthalmic Suspension in the Treatment of Inflammation Following Cataract Surgery: Adaptive Design Study Timothy L. Comstock, OD Oliver D. Schein, MD Tuyen Ong, MD Karen Kesler, PhD Disclosures: T Comstock and T Ong are employees of Bausch & Lomb, Inc. O Schein is consutlant for Bausch & Lomb, Inc. Karen Kesler is an employee of Rho, Inc. which conducted the statistical analysis.

  2. Purpose To identify the most effective drug concentration and dose frequency of mapracorat (BOL-303242-X), a novel selective glucocorticoid receptor agonist (SEGRA), for the treatment of inflammation following uncomplicated cataract surgery.

  3. Methods Phase II, multicenter, randomized, double-masked, parallel-group, vehicle-controlled, dose ranging study. Subjects were aged ≥18 years with postoperative anterior chamber (AC) cells of ≥Grade 2 (6-15 cells) on the day following uncomplicated cataract surgery. Subjects expecting to require concurrent ocular therapy with topical NSAIDs, mast cell stabilizers, antihistamines, or decongestants, or systemic NSAIDs or systemic/ocular corticosteroids were excluded.

  4. Visit 3 [Post-op Day 1] • Clinical assessment of ocular symptoms • Eye examination (VA, IOP, biomicroscopy) • AEs & concomitant medications • Determination of eligibility • Visit 2 [Surgery] • AEs & concomitant medications • Visit 1 [Screening](≤14 days prior to surgery) • Eligibility assessment • Clinical assessment of ocular symptoms • Eye examination (VA, IOP, biomicroscopy, fundoscopy) • AEs & concomitant medications • Visit 6 [Day 15 ±1] • Clinical assessment of ocular symptoms • Eye examination (VA, IOP, biomicroscopy, fundoscopy) • AEs & concomitant medications • Visit 7 [Day 18 ±1] • Clinical assessment of ocular symptoms • Eye examination (VA, IOP, biomicroscopy) • AEs and concomitant medications • Visit 4 [Day 3 ±1] • Clinical assessment of ocular symptoms • Eye examination (VA, IOP, biomicroscopy) • AEs & concomitant medications • Visit 5 [Day 8 ±1] • Clinical assessment of ocular symptoms • Eye examination (VA, IOP, biomicroscopy) • AEs & concomitant medications Mapracorat Vehicle Methods Eligible subjects self-administered 1-2 drops of study treatment (mapracorat 1%, 2%, 3% or vehicle) QD, BID, or QID for 14 days and completed 7 visits.

  5. Methods Primary efficacy endpoint: Proportion of subjects with complete resolution of AC cells at visit 5 (postoperative day 8) Secondary efficacy endpoints: Proportion of subjects with Grade 0 pain at visit 5 and at each visit Resolution of AC cells, AC flare and overall AC inflammation at each visit Safety endpoints: Incidence of ocular and non-ocular adverse events (AEs) Change from baseline in intraocular pressure (IOP), visual acuity (VA), and biomicroscopy and ophthalmoscopy findings

  6. Results: Subjects 415 subjects were randomized and included in the ITT population Subjects ranged in age from 22 to 90 years with a mean (SD) age of 67.8 (10.4) years. The median ages and proportion of male and female subjects were similar for all treatment groups

  7. Results: Complete Resolution of AC Cells at Visit 5 (postoperative day 8)—Primary Efficacy Endpoint • The mapracorat 2% QID and all 3% dose frequencies were highly significantly better than vehicle for resolution of AC cells (28.3%, 25.4%, 25.0% and 30.0%, respectively vs. 5% for vehicle). † † † † * * % Subjects with complete Resolution *P<0.05, †P<0.0005

  8. Results: Grade 0 Pain at Visit 5 (postoperative day 8) • The mapracorat 2% QID and all 3% dose frequencies were significantly better than vehicle for pain resolution (78.3%, 71.2%, 75.0% and 70.0%, respectively vs. 50% for vehicle). * * * * % Subjects with Grade 0 Pain *P<0.05

  9. Results: Adverse Events Serious Adverse Events (SAEs) No non-ocular SAEs 2 treatment-emergent ocular SAEs Cystoid macular edema (CME; 3% QD group, possibly related to the study group and probably related to study procedure) Subretinal neovascularization (3% BID group, unrelated to the study drug or study procedure) Treatment-Emergent and Related Non-Ocular AE’s 3 events total Rash (Vehicle group) Headache (2% QID group) Nausea –(3% QD group)

  10. Results: Adverse Events

  11. Results: Mean IOP for Each Visit, Safety Population • Mean IOP did not change from baseline for any treatment. • Four reports of increased IOP ≥10 mm Hg (1 vehicle, 2 mapracorat 1% BID, 1 mapracorat 3% BID) were not dose related and none exceeded 30 mm Hg. Mean IOP (mmHg)

  12. Conclusions Mapracorat 2% QID treatment and all 3% dose frequencies (QD, BID, QID) demonstrated statistically significant improvements in both AC cells and Grade 0 pain at visit 5 (postoperative day 8) compared with vehicle. Results for secondary endpoints, including results at visit 6 (day 15) and visit 7 (day 18), were consistent with primary outcomes (data not shown) Treatment related adverse effects were infrequent in all treatment groups IOP effects were similar to vehicle.

More Related